A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial

PostTraumatic Stress Disorder Clinical Trial

Official title:

A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956902
• Other study ID #: 16-107IF
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2023
• Source: Ontario Shores Centre for Mental Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tests whether people receiving clinician support to use a mobile application on their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than those who do not. Half of the participants will receive the clinician supported smartphone application intervention and the other half will remain on the waiting list.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• on the waiting list for the Ontario Shores traumatic stress clinic;
• score = 31 on the PCL-5
• have access to a smartphone or tablet to which they are willing to download the app.

Exclusion Criteria:

• active suicidal ideation

Related Conditions & MeSH terms

• PostTraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Clinician supported smartphone application intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Shores Centre for Mental Health Sciences	US Department of Veterans Affairs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptom severity	Change in PTSD checklist (PCL-5) score	8 weeks
Secondary	Clinically significant change in PTSD symptom severity	Proportion of participants with a PCL-5 score less than 31	8 weeks
Secondary	Change in Depression Severity	Change in patient health questionnaire 9 (PHQ-9) score	8 week
Secondary	Average App Use per Week (Intervention group only)	Self-report app use will be collected by the clinician at each of sessions 2-4 by asking "on average, how many times did you use the app per day (or per week, if less than once per day). The clinician will also ask which of the four main functions were used and which symptom management tools were used most and were most helpful.	8 weeks
Secondary	Goal Achievement (Intervention group only)	At each of sessions 1-3, the clinician will help the participant set goals, which will be documented. At each of sessions 2-4 the clinician will ask the participant to self-report goal achievement, which will be documented	8 weeks
Secondary	Clinician Fidelity to Protocol	A fidelity checklist has been created for this protocol, which will be completed over the course of the intervention. The form will be updated upon completion of each clinician session.	8 weeks